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BOTOX® is a type of medicine that is made from living things.1 These medicines are referred to as biological products—or biologics for short.1 In contrast, medicines made by mixing chemicals in a laboratory are called conventional drugs.1

Because many biological products are large proteins and are harder to break down, they must be injected into the body instead of being given orally.2 It is also important to understand that no two biological products are the same. Each botulinum toxin product and its Unit dosing is unique and different, and not interchangeable, which means that one product cannot take the place of another.3

Botulinum toxin products differ in the following areas:

  • Dosing
  • Manufacturing
  • Potency
  • Adverse events

Botulinum neurotoxin products are not interchangeable even if they contain the same type of protein, known as a serotype. BOTOX® is a type A product and is not the same as another type A neurotoxin.

As with any drug, patients receiving biologics, such as botulinum toxins, should start with the lowest effective dose for that product. The dose can then be increased by small increments at each subsequent treatment session until a satisfactory result is achieved. With botulinum toxin therapy, treatment is recommended no more than every 3 months. Thus, optimum therapeutic response may take several months to attain.

Learn more about biologics by downloading Understanding the Differences between Botulinum Neurotoxins Brochure.

References
1. US Food and Drug Administration. What are "biologics" questions and answers. US Food and Drug Administration Web site. http://www.fda.gov/aboutfda/centersoffices/cber/ucm133077.htm. Updated July 10, 2009. Accessed July 17, 2009.
2. Cleland JL, Daugherty A, Mrsny R. Emerging protein delivery methods. Curr Opin Biotechnol. 2001;12(2):212-219.
3. US Food and Drug Administration. Follow-up to the February 8, 2008, early communication about an ongoing safety review of BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) and Myobloc® (Botulinum Toxin Type B). US Food and Drug Administration Web site. http://www.fda.gov/drugs/drugsafety
/postmarketdrugsafetyInformationforpatientsandproviders/drugsafetyinformationforheathcareprofessionals
/ucm143819.htm. Updated June 18, 2009. Accessed July 17, 2009.

Myobloc is a registered trademark of Solstice Neurosciences, Inc.
Indications
BOTOX® is a prescription medicine that is injected into muscles and used:
  • to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults
  • to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX®:
  • Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of BOTOX®, usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX®
  • Swallowing problems may last for several months. People who already have swallowing or breathing problems before receiving BOTOX® have the highest risk of getting these problems
  • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, and trouble swallowing
These symptoms can happen hours to weeks after you receive an injection of BOTOX®.

These problems could make it unsafe for you to drive a car or do other dangerous activities. See “What should I avoid while receiving BOTOX®?” in Medication Guide.

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat severe underarm sweating, blepharospasm, or strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.

BOTOX® can cause serious side effects. Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. Symptoms of an allergic reaction to BOTOX® may include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BOTOX®. For more information, ask your doctor or pharmacist.

For additional information refer to Medication Guide. This Medication Guide summarizes the most important information about BOTOX®. If you would like more information, talk with your doctor.

Please see full product information, including Medication Guide about BOTOX®.
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